Good Clinical Practice (GCP) For Clinical Trials Involving Investigational Medicinal Products

GCP training is a key requirement for anyone involved in the conduct of clinical research.

“GCP is an international, ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects”. (ICH-GCP)

Everyone involved in the conduct of clinical research must have training to ensure they are best prepared to carry out their duties. This legislative requirement set out in The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) applies to all trials involving Investigational Medicinal Products undertaken within England.

All new researchers are required to attend a face to face session. For those who have undertaken GCP training before an eLearning Refresher only session is available.

It is currently a requirement that all researchers attend a GCP course every three years. After attending the initial face-to-face course, one online refresher course can be completed before attendance at another face-to-face session is required.

Please be aware that the certificate is valid for 3 years from the date of certification.

How do I book a place on the GCP sessions?
These sessions can be booked via HELM. If you do not have a HELM account please contact RITraining@uhl-tr.nhs.uk and a member of the team will assist you in setting up an account.

Please view our calendar of training sessions  to see the upcoming sessions, these can also be seen via your HELM account.

To view upcoming sessions in HELM, go to the tab “My training” select course catalogue and type in GCP.

We regret that we cannot take bookings from candidates from outside the University of Leicester or Leicester’s Hospitals for any of our courses.

Other Providers:
National Institute of Health Research
The NIHR provide face to face GCP and GCP refresher training sessions as well as an eLearning course.